CLARITIN Drug Patent Profile
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Which patents cover Claritin, and when can generic versions of Claritin launch?
Claritin is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs.
The generic ingredient in CLARITIN is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Claritin
A generic version of CLARITIN was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30th, 2003.
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Summary for CLARITIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 148 |
| Clinical Trials: | 27 |
| Patent Applications: | 3,953 |
| Drug Sales Revenues: | Drug sales revenues for CLARITIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLARITIN |
| What excipients (inactive ingredients) are in CLARITIN? | CLARITIN excipients list |
| DailyMed Link: | CLARITIN at DailyMed |
Recent Clinical Trials for CLARITIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Andover Research Eye Institute | Phase 4 |
| Rutgers, The State University of New Jersey | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
US Patents and Regulatory Information for CLARITIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | CLARITIN | loratadine | CAPSULE;ORAL | 021952-001 | Jun 16, 2008 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | CLARITIN HIVES RELIEF REDITAB | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 020704-003 | Nov 19, 2003 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | CLARITIN | loratadine | TABLET;ORAL | 019658-002 | Nov 27, 2002 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | CLARITIN REDITABS | loratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021993-001 | Dec 12, 2006 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Healthcare Llc | CLARITIN | loratadine | TABLET, CHEWABLE;ORAL | 021891-002 | Nov 21, 2018 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for CLARITIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Healthcare Llc | CLARITIN | loratadine | TABLET;ORAL | 019658-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Healthcare Llc | CLARITIN | loratadine | TABLET;ORAL | 019658-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Healthcare Llc | CLARITIN | loratadine | SYRUP;ORAL | 020641-002 | Nov 27, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLARITIN
See the table below for patents covering CLARITIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 1082117 | SIROP A ANTIHISTAMINES STABILISE CONTENANT UN STABILISANT ACIDE AMINOPOLYCARBOXYLIQUE (A STABILIZED ANTIHISTAMINE SYRUP CONTAINING AMINOPOLYCARBOXYLIC ACID AS STABILIZER) | ⤷ Sign Up |
| Hungary | T38332 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9962516 | ⤷ Sign Up | |
| Guatemala | 199900072 | JARABE ANTIHISTAMINICO ESTABILIZADO. | ⤷ Sign Up |
| Australia | 5737486 | ⤷ Sign Up | |
| Egypt | 23908 | Stabilized antihistamine syrup | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLARITIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1110543 | SPC/GB08/005 | United Kingdom | ⤷ Sign Up | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022. |
| 0152897 | C00152897/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
| 0152897 | SPC/GB01/012 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115 |
| 1110543 | 08C0004 | France | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
| 0152897 | 2001C/013 | Belgium | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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